No-touch packaging configurations and application methods for hydrophilic intermittent catheters

ABSTRACT

A packaging assembly for a hydrophilic catheter permits activation of a hydrophilic coating on the catheter and introduction of the catheter into a urethra in a sterile condition. A rupturable pouch containing a lubricant is enclosed in a chamber of the packaging assembly also occupied by the catheter. A portion of the packaging assembly in which the pouch is disposed is removable from the remaining portion of the packaging assembly following activation of the hydrophilic coating, such as by tearing along a line beginning at one or more tear notches, ripping along a perforation, cutting, or some combination thereof. The remaining portion of the packaging assembly may then be manipulated to introduce the catheter into a urethra, isolating at least an insertable portion of the catheter from human hands prior to contact with the urethra.

REFERENCE TO RELATED APPLICATIONS

This disclosure claims priority to, and is entitled to the benefit of the filing dates of, U.S. Provisional Application No. 60/515,606, filed Oct. 30, 2003, and 60/536,065, filed Jan. 13, 2004, for all subject matter commonly disclosed therein.

FIELD OF THE DISCLOSURE

This disclosure relates generally to packaging of urinary catheters and, more specifically, to packaging facilitating exposure of a hydrophilic coating of an intermittent catheter to a lubricant while contained within the packaging as well as sterile application of the lubricated catheter.

BACKGROUND

Current competitive hydrophilic intermittent urinary catheters are packaged in such a way that the user is required to touch the catheter for insertion. Any exposure of a catheter to a non-sterile environment prior to insertion increases the potential for bacteria to be deposited on the catheter, leading to an increased potential for the catheter user to develop a urinary tract infection (UTI). It would therefore be desirable for a hydrophilic intermittent catheter to be packaged in such a way that its hydrophilic coating could be activated while the catheter is still in the package, and so that the catheter may be manipulated and advanced through the packaging, allowing application of the catheter without the user having to touch the actual catheter.

The present invention includes package instructions and cut or tear-zone product packaging features so that the need for the user to touch the hydrophilic intermittent catheter is either minimized or preferably entirely eliminated. In this manner, the cut or tear-zone product packaging features provide the ability to deliver a “no-touch” approach to catheter insertion.

Some competitive hydrophilic intermittent catheters are packaged in water as ready-to-use catheters. Other competitive hydrophilic intermittent catheters are packaged with a water packet for easy activation of the hydrophilic coating on the surface in preparation for use of the catheter. For example, Rochester Medical Corporation has a configuration of this type in which the water packet is provided adjacent the insertion end of the catheter (i.e., the end remote from the funnel end), but the user is required to handle the catheter for urethral insertion by peeling open the funnel end of the product packaging and then removing the catheter by pulling directly on the funnel through the open end of the packaging. Because the user must insert the opposite (eyelet) end of the catheter into the urethra after removal from the product packaging, it will be appreciated that handling of the catheter by the user cannot be avoided.

SUMMARY

The present invention can maintain the basis of packaging for a hydrophilic intermittent catheter (i.e., a catheter in water), but it provides a packaging configuration in which the user is instructed to remove a part of the packaging while allowing for the remaining packaging to be used as a no-touch applicator sleeve. The user prepares the packaged catheter by, first, rupturing a foil water packet that is included within a cavity that holds the catheter and, then, tipping the packaging back and forth in order to fully hydrate the hydrophilic intermittent catheter.

In some embodiments, the packaging may include printed instructions for the user to cut (for example using user provided scissors) through a packaging heat seal edge joint perpendicular to the catheter's orientation along a line printed on the eyelet end of the packaging, which may include, for example, “Do Not Cut Beyond” indicia. After the packaging has been cut to the extent indicated by such indicia, the end of the packaging adjacent the eyelet end of the catheter can be removed by the user tearing it away from the remainder of the packaging.

In another embodiment, the need for user cutting is eliminated by perforating the packaging to allow the user to tear through the heat seal in the same eyelet end of the packaging perpendicular to the catheter's orientation.

In still another embodiment, notching is provided on opposite sides of the packaging. The notching allows the user to tear through the heat seal in the same eyelet end of the packaging perpendicular to the catheter's orientation. Specifically, the packaging can be provided with notching on either side of a designated separation region to thereby decrease the force needed to separate the end from the remainder of the packaging, while at the same time exposing the eyelet end of the catheter for insertion.

In any of the foregoing packaging configurations, the user can proceed to hold the catheter firmly within the packaging in one hand and to hold the packaging proximal the opening formed near the eyelet end of the catheter in the other hand. The user may then initiate insertion of the exposed eyelet end of the catheter into the urethra while using the hand holding the packaging proximal the opening near the eyelet end to gradually slip the packaging away from the eyelet end toward the funnel end as the catheter is inserted further into the urethra. As a result, and without the need to touch the catheter, it will be understood that the insertion of the catheter is carried out by manipulating the catheter solely through handling of the packaging films as the catheter is inserted further into the urethra.

Any of the embodiments of the present disclosure may be varied by including a peel-away sheet or wrapper portion. Printed instructions may also be provided to direct the user to peel open the packaging at the funnel end of the catheter to drain the water after the catheter has been fully hydrated, i.e. following the rupturing of the foil water packet and tipping of the sealed packaging back and forth.

In certain embodiments, the printed instructions may further direct the user to grasp the funnel on the catheter and to pull the funnel end of the catheter a few inches out of the packaging through the end of the packaging that was peeled open to accommodate draining the water. The printed instructions may additionally direct the user to withdraw the funnel end of the catheter until the insertion end or tip of the catheter is spaced from the closed end of the packaging and is also spaced a short distance from the spent foil water packet. Next, the printed instructions may direct the user to tear or cut through the packaging between the spent foil water packet and the insertion end or tip of the catheter, for example along a notched tear line, a perforation, or a printed or scored cutting line, to separate the closed end (including the spent foil water packet) from the remainder of the packaging. Finally, the printed instructions may direct the user to grasp the funnel on the catheter and push the catheter back through the remaining packaging to expose the insertion end or tip through the cut end for no-touch application of the catheter using the packaging as an applicator sleeve.

From the foregoing, it will be appreciated that the no-touch application methods and hydrophilic catheter packaging configurations disclosed herein permit the user to hold the catheter firmly within the packaging, and that in at least certain embodiments, the catheter may be held firmly within the packaging that remains after peeling open the packaging at the funnel end of the catheter, cutting or tearing the packaging to completely separate the closed end including the spent foil water packet, and pushing the catheter through the packaging to expose the insertion end or tip. The user may initiate insertion of the exposed insertion or eyelet end of the catheter into the urethra while using the hand holding the packaging to gradually slip the packaging away from the eyelet end toward the funnel end as the catheter is inserted further into the urethra. As a result, and without any need for the user to ever touch the catheter after the catheter and packaging have been prepared using the steps described above, and as explained further in the following detailed description of the preferred embodiments, the insertion of the catheter is carried out simply by manipulating the catheter solely through handling of the films that make up or are part of the packaging as the catheter is inserted further into the urethra.

With the foregoing, the present invention overcomes the increased potential of UTIs that occurs with catheter handling. The “no-touch” approach of the present invention minimizes, and potentially eliminates, the UTI potential because it avoids or eliminates contamination of the catheter by bacteria on the hands of the user during insertion into the urethra. Further, the catheter's flexible silicone construction paired with the packaging allows the catheter to remain stable to make insertion easier for the user.

By utilizing the “no-touch” application approach, the packaging facilitates insertion for softer catheters because gripping of the catheter through the films of the packaging serves to “stiffen” or stabilize the catheter as an aid to insertion.

DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 is a top plan view of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;

FIG. 2 is an elevation view of the package assembly of FIG. 1, wherein the pouch containing the lubricant has been ruptured;

FIG. 3 is an elevation view of the package assembly of FIG. 1, showing separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging;

FIG. 4 is an elevation view of the package assembly of FIG. 1, after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, exposing a distal end of the catheter;

FIG. 5 is a cross-sectional view taken along lines 5-5 of FIG. 3;

FIG. 6 is a top plan view of another embodiment of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;

FIG. 7 is an elevation view of the package assembly of FIG. 6, wherein the pouch containing the lubricant has been ruptured;

FIG. 8 is an elevation view of the package assembly of FIG. 6 showing separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging;

FIG. 9 is an elevation view of the package assembly of FIG. 1, after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, exposing a distal end of the catheter;

FIG. 10 is a top plan view of a third embodiment of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;

FIG. 11 is an elevation view of the package assembly of FIG. 10, wherein the pouch containing the lubricant has been ruptured;

FIG. 12 is an elevation view of the package assembly of FIG. 10, showing separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging;

FIG. 13 is an elevation view of the package assembly of FIG. 10, after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, exposing a distal end of the catheter;

FIG. 14 is an elevation view of a fourth embodiment of a package assembly for an intermittent hydrophilic catheter and pouch containing a lubricant;

FIG. 15 is an elevation view of the package assembly of FIG. 14, wherein the pouch containing the lubricant has been ruptured;

FIG. 16 is an elevation view of the package assembly of FIG. 14, demonstrating a manner in which any of the package assemblies disclosed herein may be manipulated following rupture of the pouch containing the lubricant in order to activate the coating of the intermittent hydrophilic catheter;

FIG. 17 is an elevation view of the package assembly of FIG. 14, showing the walls of packaging assembly peeled apart at a funnel end of the catheter;

FIG. 18 is an elevation view of the package assembly of FIG. 14, showing the funnel end of the catheter pulled out through the peeled-apart opening of the packaging assembly;

FIG. 19 is an elevation view of the package assembly of FIG. 14, showing the separation of a first portion of the packaging surrounding the pouch containing the lubricant from a remaining portion of the packaging; and

FIG. 20 is an elevation view of the package assembly of FIG. 14, after the first portion of the packaging surrounding the pouch containing the lubricant has been completely removed from the remaining portion of the packaging, and showing the catheter being advanced through the remaining portion of the packaging for use.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the embodiments illustrated in the several views of the drawing, the cut, perforated tear lines, and notched tear lines cause the eyelet end of the catheter to be exposed upon severing and removal of the end of the packaging. In alternative embodiments, the packaging is formed such that the cut, perforated tear lines, and notched tear lines are located beyond the eyelet end of the catheter upon severing and removal of the end of the packaging. If so formed, the catheter can be gripped through the packaging and manipulated by the user to cause the eyelet end to be exposed to initiate the insertion of the catheter into the urethra.

A first embodiment of a packaging assembly 10 for an intermittent hydrophilic catheter 12 is shown in FIGS. 1-5. The packaging assembly includes a first sheet 14 and a second sheet 16. The first sheet 14 and second sheet 16 are secured to one another at an edge seal 15, for example by heat sealing, and the first and second sheets 14, 16 together define a catheter-receiving chamber 18. A pouch 20 containing a lubricant 22, such as water, is disposed within the catheter-receiving chamber 18, and is located in a first end 24 of the chamber 18. In this first embodiment, the catheter 12 has a distal end 26 also disposed in the first end 24 of the chamber 18. The catheter 12 further includes a funnel 28 disposed on a proximal end 30 thereof. The proximal end 30 of the catheter 12 is located in a second end 32 of the catheter-receiving chamber 18.

The packaging assembly 10 is provided with at least one notch 34, and preferably an opposing notch 36. These notches 34, 36 facilitate tearing a portion 38 of the packaging assembly 10 containing the pouch 20 to separate that portion 38 from a remaining portion 40 of the packaging assembly 10.

The sheets 14, 16 of the packaging assembly 10 are preferably non-rigid, and may, for example, be made of foil. In order to activate a hydrophilic coating on the surface of the catheter 12, a user firmly presses on the pouch 20, which is preferably formed of an easily breakable foil, until it ruptures, thereby releasing lubricant 22 contained therein. Using a motion such as that illustrated in FIG. 16, the user then tilts the packaging assembly 10 back and forth, or otherwise maneuvers the packaging assembly 10, in order to distribute the lubricant 22 over the entirety of the coated portion of the catheter 12.

Once the lubricant 22 is distributed over the coated portion of the catheter 12, the catheter 12 is lubricated and ready for use. The user initiates a tear at one of the notches 34, 36, separates the first portion 38 from the remaining portion 40 of the packaging assembly 10, as shown in FIG. 3, and removes the first portion 38, exposing the distal end 26 of the catheter 12, as shown in FIG. 4. The user may then manipulate the catheter 12 through the walls 14, 16 of the packaging assembly 10 so as to introduce the catheter 12, distal end 26 first, into the urethra.

A second embodiment of the packaging assembly 100 is shown in FIGS. 6-9. As the second embodiment of the packaging assembly 100 has many elements in common with the first embodiment of the packaging assembly 10, reference numbers in FIGS. 6-9 representing common elements in the two embodiments are the same as the reference numbers in FIGS. 1-5, increased by a factor of 100, and so as to avoid repetition, a detailed discussion of all elements of the second embodiment of the packaging assembly 100 is omitted.

The second embodiment of the packaging assembly 100 utilizes a perforation line 135 along which a first portion 138 of the packaging assembly 100 can be separated from the remaining portion 140 once the hydrophilic coating of a catheter 112 has been activated.

A third embodiment of a packaging assembly 200 is illustrated in FIGS. 10-13. As with the second: embodiment, this third embodiment of the packaging assembly 200 has many elements in common with the first embodiment of the packaging assembly 10. Thus, reference numbers in FIGS. 10-13 representing common elements in the two embodiments are the same as the reference numbers in FIGS. 1-5, increased by a factor of 200, and so as to avoid repetition, a detailed discussion of all elements of the third embodiment of the packaging assembly 200 is omitted. The third embodiment of the packaging assembly 200 utilizes a pair of cutting lines 233, 237. Once a user cuts the packaging assembly 200 along the cutting lines 233, 237 using, for example, a pair of scissors 250, a remaining length 235 between a terminus of each of the cutting lines 233, 237 may be torn by the user to permit separation of a first portion 238 of the packaging assembly 200 from the remaining portion 240, as shown in FIG. 12, once the hydrophilic coating of a catheter 212 has been activated. While cutting along the cutting lines 233, 237, the user must exercise caution to avoid cutting any portion of the catheter 212.

Turning to FIGS. 14-20, a fourth embodiment of a packaging assembly 300 is shown. The fourth embodiment also has many elements in common with the first embodiment of the packaging assembly 10, so reference numbers in FIGS. 14-20 representing common elements in the two embodiments are the same reference numbers in FIGS. 1-5, increased by a factor of 300, and so as to avoid repetition, a detailed discussion of all elements of the fourth embodiment of the packaging assembly 300 is omitted.

In this fourth embodiment, after activation of the hydrophilic coating, the first and second sheets 314, 316 of the packaging assembly 300 are pulled apart to permit drainage of the lubricant 322 from the chamber 318 and withdrawal of the funnel end 328 of the catheter 312. By withdrawing the funnel 328 of the catheter 312 a short distance through an opening 352 created by pulling apart the first and second sheets 314, 316, the distal end 326 of the catheter 312 is withdrawn from the first end 324 of the packaging assembly 300 containing the pouch 320. By withdrawing the distal end 326 of the catheter 312 a sufficient distance from the first portion 338 of the packaging assembly 300, a user may then cut the entire first portion 338 from the remaining portion 340 of the packaging assembly 300 without having to first cut through only a portion of the width of the packaging assembly, then tearing the remainder, as in the third embodiment.

As shown in FIG. 20, after advancing the funnel end 328 back into the packaging assembly 310 to expose the distal or insertion end 326, the catheter 312 is then ready for use. The remaining portion 340 of the packaging assembly may be used to manipulate the catheter 312 for insertion into the urethra without the user having to physically touch the lubricated body of the catheter 312. Although the funnel end 328 of the catheter 312 is pulled out of the packaging assembly 300 prior to insertion of the catheter 312, this limited exposure of the catheter 312 does not compromise the sterility of the insertable portion of the catheter 312. The funnel end 328 of the catheter 312 is only pulled out of the packaging assembly 300 a sufficient distance so that the distal end 326 is pulled clear of the first portion 338 of the packaging assembly. No portion of the catheter 312 that physically comes into contact with the urethra is withdrawn through the opening 352 prior to insertion of the catheter 312.

As illustrated in FIG. 5, as a further aspect of the packaging of the present invention, the end of the packaging opposite the eyelet end of the catheter can be formed so it can be opened by the user in an easy fashion. This easy-open feature permits drainage of the lubricant after the catheter has been lubricated, and it also permits drainage of urine directly into the toilet through the funnel end of the catheter opposite the insertion end. For this purpose, the packaging may be formed such that the front and back walls 14, 16 extend unattached beyond the edge seal 15 to permit the walls, which may be made of foil, to be gripped by the user to peel open this end.

Once this has been done, the end of the catheter 12 opposite the eyelet, or insertion, end (which may have a funnel 28) can be made to extend outwardly of the peeled-open packaging to accomplish the direct drainage of urine through the catheter into the toilet.

With the foregoing understanding, it will be appreciated that the catheter tip can be made ready for insertion without the need to touch the catheter either by exposing it upon severing and removing the end of the packaging or by manipulating the catheter through the packaging to cause the tip to be clear of the packaging. Further, the packaging does not interfere with insertion and the user gets the added benefit of controlled no-touch insertion with the use of the packaging sleeve. Because of the ability to provide controlled, no-touch insertion using any of the foregoing forms of opening the packaging and exposing the eyelet end of the catheter, it is possible to overcome the problems associated with current hydrophilic intermittent catheters which are very slippery to touch and handle. It will also be appreciated that the invention is not limited to the embodiments described herein, and that variations may be made that are within the scope of the appended claims. 

1. A packaging assembly for sterile application of a hydrophilic catheter comprising: a first sheet; a second sheet heat sealed to the first sheet to form a chamber defined by the first and second sheets; a hydrophilic catheter disposed in the chamber, said catheter having a distal end initially located adjacent a first end of the chamber and a proximal end initially located adjacent a second end of the chamber; a pouch disposed within the chamber and located adjacent the first end of the chamber; means for separating a first portion of the packaging assembly containing the pouch from a remaining portion of the packaging assembly.
 2. The packaging assembly of claim 1, wherein the means for separating the first portion of the packaging assembly containing the water pouch from the remaining portion of the packaging assembly includes at least one of: (a) providing one or more tear notches in the first and second sheets spaced a greater distance from the first end of the chamber than a length of the pouch, (b) providing a perforation line facilitating controlled ripping therealong, the perforation line extending along substantially an entire width of the packaging assembly and spaced a greater distance from the first end of the chamber than the length of the pouch; (c) one or more cutting lines indicated on at least one of the first and second sheets through which a cutting device is used, said one or more cutting lines spaced a greater distance from the first end of the chamber than the length of the pouch; or any combination of (a), (b), and (c).
 3. The packaging assembly of claim 1, wherein the distal end of the catheter initially overlies the pouch.
 4. The packaging assembly of claim 3, wherein the first sheet and second sheet may be peeled apart at one end thereof to create an opening for withdrawal of the proximal end of the catheter a distance sufficient to remove the distal end of the catheter from its initial location overlying the pouch without removing the distal end of the catheter from the packaging assembly.
 5. The packaging assembly of claim 4, wherein the catheter includes a hydrophilic coating extending over a lengthwise portion thereof, and the catheter being of such a length that none of an insertable length of the coated portion of the catheter need be outside the chamber upon said withdrawal of the proximal end of the catheter.
 6. The packaging assembly of claim 1, wherein the one or more cutting lines are indicated as printed indicia on an outer surface of at least one of the first and second sheets.
 7. A method for activating a hydrophilic coating of a catheter and for introducing the catheter into a urethra, comprising: providing a packaging assembly having a first sheet and a second sheet, said first and second sheets being sealed to one another and defining a chamber enclosing a catheter having a hydrophilic coating therebetween; providing a rupturable pouch within the chamber, said pouch containing a lubricant; rupturing the pouch; maneuvering the packaging assembly to distribute the lubricant across the hydrophilic coating of the catheter; removing an end of the packaging assembly containing the pouch; and manipulating the catheter within the packaging assembly to advance the catheter in a direction toward an opening created by said removal of the end of the packaging assembly containing the pouch while introducing the catheter into a urethra.
 8. The method of claim 7, wherein the packaging assembly is provided with at least one tear notch in the first and second sheets spaced a greater distance from a first end of the chamber than a length of the pouch, and said pouch being disposed adjacent the first end, and in removing the end of the packaging assembly containing the pouch, tearing along a line beginning at said at least one tear notch.
 9. The method of claim 7, wherein the packaging assembly is provided with a perforation line facilitating controlled ripping therealong, the perforation line extending along substantially an entire width of the packaging assembly and spaced a greater distance from a first end of the chamber than a length of the pouch, and said pouch being disposed adjacent the first end, and in removing the end of the packaging assembly containing the pouch, ripping along said perforation line.
 10. The method of claim 7, wherein the packaging assembly is provided with one or more cutting lines indicated on at least one of the first and second sheets, said one or more cutting lines spaced a greater distance from a first end of the chamber than a length of the pouch, and said pouch being disposed adjacent the first end, and in removing an end of the packaging assembly containing the pouch, cutting along said one or more cutting lines, and in removing the end of the packaging assembly containing the pouch, tearing along a line beginning at a terminus of said one or more cutting lines.
 11. The method of claim 7, wherein a distal end of the catheter initially overlies the pouch, and further comprising, prior to removing the end of the packaging assembly containing the pouch, partially separating the first and second sheets from one another to create an opening at an end of the packaging assembly adjacent a funnel of the catheter; and withdrawing the funnel of the catheter through the opening a sufficient distance for the distal end of the catheter to no longer overlie the pouch.
 12. The method of claim 11, wherein in removing an end of the packaging assembly containing the pouch, cutting along a portion of the packaging assembly between the pouch and the distal end of the catheter.
 13. The method of claim 7, wherein in maneuvering the packaging assembly to distribute the lubricant across the hydrophilic coating of the catheter, the packaging assembly is tilted in a back and forth motion by repeatedly positioning a first end of the packaging assembly higher than a second end of the packaging assembly and then positioning the second end of the packaging assembly higher than the first end of the packaging assembly. 